Description and Brand Names

US Brand Name

Levaquin

Descriptions

Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to prevent an anthrax infection after a person has been exposed to anthrax. This medicine is also used to treat and prevent plague (including pneumonic and septicemic plague).

Levofloxacin belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Solution

Tablet

Syrup

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use is not recommended for infants, children, or teenagers. However, this medicine may be used in children 6 months of age and older to treat plague and to prevent an anthrax infection after a possible exposure.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levofloxacin in the elderly. However, elderly patients are more likely to have age-related tendon disorders (including tendon rupture) and kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving levofloxacin.

Pregnancy

Information about this levofloxacin-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Cisapride

Dronedarone

Mesoridazine

Pimozide

Piperaquine

Sparfloxacin

Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose

Acecainide

Acetohexamide

Alfuzosin

Alogliptin

Amiodarone

Amitriptyline

Amoxapine

Anagrelide

Apomorphine

Aripiprazole

Arsenic Trioxide

Artemether

Asenapine

Astemizole

Azimilide

Azithromycin

Bedaquiline

Benfluorex

Bretylium

Buserelin

Canagliflozin

Chloroquine

Chlorpromazine

Chlorpropamide

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Cyclobenzaprine

Dabrafenib

Dapagliflozin

Dasatinib

Delamanid

Desipramine

Deslorelin

Disopyramide

Dofetilide

Dolasetron

Domperidone

Droperidol

Erythromycin

Escitalopram

Exenatide

Fingolimod

Flecainide

Fluconazole

Fluoxetine

Formoterol

Gatifloxacin

Gemifloxacin

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Gonadorelin

Goserelin

Granisetron

Guar Gum

Halofantrine

Haloperidol

Histrelin

Ibutilide

Iloperidone

Imipramine

Insulin Aspart, Recombinant

Insulin Degludec

Insulin Detemir

Insulin Glargine, Recombinant

Insulin Glulisine

Insulin Human Isophane (NPH)

Insulin Human Regular

Insulin Lispro, Recombinant

Ivabradine

Ketoconazole

Lapatinib

Leuprolide

Linagliptin

Liraglutide

Lopinavir

Lumefantrine

Mefloquine

Metformin

Methadone

Metronidazole

Mifepristone

Miglitol

Moricizine

Moxifloxacin

Nafarelin

Nateglinide

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pasireotide

Pazopanib

Perflutren Lipid Microsphere

Perphenazine

Pioglitazone

Posaconazole

Pramlintide

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Rasagiline

Repaglinide

Rosiglitazone

Salmeterol

Saquinavir

Saxagliptin

Sematilide

Sevoflurane

Sitagliptin

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Tedisamil

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Theophylline

Tizanidine

Tolazamide

Tolbutamide

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Triptorelin

Vandetanib

Vardenafil

Vemurafenib

Vilanterol

Vildagliptin

Vinflunine

Voriconazole

Warfarin

Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Betamethasone

Calcium

Corticotropin

Cortisone

Cosyntropin

Deflazacort

Dexamethasone

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Fludrocortisone

Fluocortolone

Hydrocortisone

Iron

Lanthanum Carbonate

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Methylprednisolone

Paramethasone

Prednisolone

Prednisone

Triamcinolone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Bradycardia (slow heartbeat) or

Diabetes or

Diarrhea or

Heart rhythm problems (eg, prolonged QT interval), or family history of or

Hypokalemia (low potassium in the blood), uncorrected or

Liver disease (including hepatitis) or

Myocardial ischemia (reduced blood supply in the heart) or

Seizures (epilepsy), or history of—Use with caution. May make these conditions worse. .

Brain disease (eg, hardening of the arteries) or

Kidney disease, severe or

Organ transplant (eg, heart, kidney, or lung), history of or

Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse.

Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Levofloxacin oral liquid should be taken 1 hour before or 2 hours after eating. You may measure your dose with a marked measuring spoon, oral syringe, or medicine cup.

Levofloxacin tablets may be taken with meals or on an empty stomach.

This medicine is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of levofloxacin.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.

If you need to take this medicine for anthrax infection or plague, your doctor will want you to begin taking it as soon as possible after you are exposed to anthrax or bacteria causing the plague.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or 2 hours after taking levofloxacin. These medicines may keep levofloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (oral solution or tablets):

For treatment of an infection:

Adults—250 to 750 milligrams (mg) once a day.

Children—Use and dose must be determined by your doctor.

For preventing anthrax infection:

Adults—500 milligrams (mg) once a day.

Children 6 months of age and older and weighing more than 50 kilograms (kg)—500 mg once a day.

Children 6 months of age and older and weighing less than 50 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 mg per kg of body weight per dose, given two times a day. However, the dose is usually not more than 250 mg.

Infants younger than 6 months of age—Use and dose must be determined by your doctor.

For treatment and prevention of plague:

Adults—500 milligrams (mg) once a day.

Children 6 months of age and older, weighing more than 50 kilograms (kg)—500 mg once a day.

Children 6 months of age and older, weighing less than 50 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 mg per kg of body weight per dose, given two times a day. However, the dose is usually not more than 250 mg.

Infants younger than 6 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Levofloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to the bones). This can occur while you are taking the medicine or after you finish using it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or have received an organ (eg, heart, kidney, or lung) transplant. Check with your doctor right away if you get sudden pain or swelling in a tendon after exercise (eg, in the ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, lightheadedness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Levofloxacin may cause serious liver problems, including hepatitis. Check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you are using this medicine.

Levofloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

If you have low blood potassium or an abnormally slow heartbeat, levofloxacin may increase your risk of having a fast, slow, or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.

If you are a diabetic patient taking insulin or diabetes medicine by mouth: Levofloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, stop taking levofloxacin and check with your doctor right away:

Some people who take levofloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn or skin rash, redness, itching, or discoloration. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.

Wear protective clothing, including a hat and sunglasses.

Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Levofloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If these reactions are especially bothersome, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

Rare

Abdominal or stomach cramps or pain (severe)

agitation

blisters

confusion

diarrhea (watery and severe) which may also be bloody

feeling that others can hear your thoughts or control your behavior

fever

pain, inflammation, or swelling in the calves of the legs, shoulders, or hands

redness and swelling of the skin

seeing, hearing, or feeling things that are not there

sensation of burning on the skin

severe mood or mental changes

skin rash, itching, or redness

trembling

unusual behavior

Incidence not known

Black, tarry stools

blurred vision

burning, numbness, tingling, or painful sensations

convulsions

cough

dark-colored urine

difficulty with breathing

difficulty with chewing, talking, or swallowing

drooping eyelids

fast or irregular heartbeat

general body swelling

hives

hoarseness

joint or muscle pain

muscle cramps, spasms, pain, or stiffness

peeling or loosening of the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe dizziness

severe tiredness

tightness in the chest

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vision changes

voice changes

weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal or stomach pain or discomfort

change in taste

constipation

dizziness

drowsiness

headache

lightheadedness

nausea

nervousness

trouble sleeping

vaginal itching and discharge

vomiting

Incidence not known

Feeling faint

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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